NCT00307827终止2 期
A Phase 2, Randomized, Double-blind, Multicenter, Dose-exploration Study of Visilizumab in Subjects With Intravenous Steroid-refractory Ulcerative Colitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Abbott
- 入组人数
- 38
- 试验地点
- 16
- 主要终点
- Proportion of subjects in each of the three visilizumab dose groups who respond to treatment in the dose-exploration portion of this study (Stage 1).
研究概览
简要总结
The purpose of this study is to assess the efficacy, immunogenicity, and safety of various doses of visilizumab in subjects with intravenous steroid-refractory ulcerative colitis (IVSR-UC) and to evaluate optimal dosing.
详细描述
PDL BioPharma, Inc. was formerly known as Protein Design Labs, Inc.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm 1
Experimental
Visilizumab low dose level
干预措施: Visilizumab (Drug)
Arm 2
Experimental
Visilizumab middle dose level
干预措施: Visilizumab (Drug)
Arm 3
Experimental
Visilizumab high dose level
干预措施: Visilizumab (Drug)
结局指标
主要结局
Proportion of subjects in each of the three visilizumab dose groups who respond to treatment in the dose-exploration portion of this study (Stage 1).
时间窗: Day 45
次要结局
- Comparison of subjects in the three visilizumab dose groups(During the course of the study)
研究者
研究点 (16)
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